generic drugs
Document destruction at an Indian generic plant
Generic drugmakers in India have been found destroying key documents on multiple occassions. Now, a "large number of torn pieces" of documents were found among three truckloads of "scrap materials" from a site run by the drugmaker Granules in Telangana, India. When confronted by FDA inspectors, STAT's Ed Silverman writes, plant management acknowledge the papers should not have been destroyed.
Other companies in India, like Cipla, Intas, and Strides Pharma have all been found to have destroyed or attempted to destroy critical records needed to ensure drug safety and compliance. The incidents raise concerns among regulators, as Indian manufacturers are responsible for about 90% of U.S. generic prescriptions.
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capitol hill
Sen. Cassidy's bid to protect small biotechs
A top Republican senator has introduced a bill, obtained by STAT, that's meant to help small biotechs avoid Medicare price negotiations. Specifically, the legislation from Sen. Bill Cassidy of Louisiana would allow "research and development-intensive small biotech manufacturers" to extend their exemption from haggling with the government over prices past 2028. It also creates a new way to determine what qualifies as a small biotech.
With President Biden in the White House and Democrats controlling the Senate, STAT's John Wilkerson writes, the bill has no chance of passing. But depending on election results, it could signal what Republicans have in store for biopharma and drug pricing next year.
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